Learn how SafetyDocs supports risk management.
About Risk Management
Risk management is a key component of the pharmacovigilance process, focused on preventing or mitigating the risks a product might pose to patients. In the context of SafetyDocs, risk management is handled using:
- Risk Management Plans
- Risk Measures
- Implementation Strategies
Risk Management Plans
A risk management plan (RMP) is a document that defines a marketed product’s safety profile, including its epidemiology, pharmacovigilance plan, post-authorization studies, and risk minimization activities. SafetyDocs supports the creation of RMPs using the following objects:
- A Core Risk Management Plan, which represents a product’s global, or company-wide, RMP
- A Local Risk Management Plan, which tailors a Core Risk Management Plan for submission to a specific local agency, such as the FDA or EMA
To learn more about managing RMPs in SafetyDocs, see Manage Risk Management Plans.
Risk Measures
A risk measure, also known as a risk minimization measure (RMM), is an element of a product’s RMP that identifies a specific risk to be tracked, managed, and measured. Based on its focus, an RMM is categorized as either routine or additional. Some examples of routine RMMs include labeling, product legal status (for example, prescription or hospital-only), and pack size. Some examples of additional RMMs (aRMMs) include demonstration kits, dispensing forms, and direct healthcare professional communications.
In the context of SafetyDocs, risk measures are created from within an existing Risk Management Plan and are defined as either Core Risk Measures or Local Risk Measures.
To learn more about managing risk measures in SafetyDocs, see Manage Risk Measures.
Implementation Strategies
An implementation strategy is an element of an RMP focused on how to implement a given risk measure. In the context of SafetyDocs, implementation strategies exist in relation to a given RMP and often include documents describing the implementation plan for a given risk measure.
As such, SafetyDocs defines implementation strategies as either Core Implementation Strategies or Local Implementation Strategies, based on their related Risk Management Plan.
To learn more about managing implementation strategies in SafetyDocs, see Manage Implementation Strategies.